Further alignment with EU standards will improve patient safety
Respondents to consultation “overwhelmingly” support move to align with EU Common Specifications.
The UK Government has announced that it intends to align with EU specifications on high risk in vitro diagnostic devices - tests on human samples for conditions including pregnancy and Covid-19, and a wide range of infections and diseases.
The announcement follows a public consultation, in which respondents “overwhelmingly” supported the proposal to repeal current regulations on Coronavirus Test Device Approvals and replace them with EU Common Specifications.
It is anticipated that alignment with the Common Specifications will reduce regulatory red tape for manufacturers, as well as ensuring the devices are made to the highest standards.
Rob Reid, Deputy Director of Innovative Devices at the Medicines and Healthcare products Regulatory Agency (MHRA), said the move will “enhance patient safety” and “make it easier for manufacturers to navigate regulatory requirements across different markets.”
The changes are expected to take effect later in 2025, when the UK Government introduces a broader package of reforms relating to the regulation of medical devices. It can be expected that these changes will improve patient safety, make life easier for manufacturers, and bring the NHS up to date with health providers across Europe.
